Vioxx Posed Heart Risk after just a few Weeks

As pharmaceutical giant Merck & Co. battles its first court case related to Vioxx in Texas, the company is gearing up for what could be an even tougher fight in a New Jersey state court in September.

Plaintiff’s attorneys are expected to use a document, released last week in the Texas court case, to undermine one of Merck’s main defenses in its planned litigation strategy: that users of the painkiller Vioxx weren’t at increased risk for heart attack or stroke until after using it daily for 18 months.

An internal company document that Merck provided to plaintiffs attorneys suggests that some Vioxx users began experiencing more heart problems than placebo takers as early as a few weeks after beginning to take the painkiller.

The document—which contains preliminary, unpublished results of a clinical trial called Victor—suggests that the elevated risk grew over time. The risk neared statistical significance at about the one-year point. Reaching statistical significance means the phenomenon isn’t due to chance. Armed with the new data, plaintiffs attorneys are expected to argue that even patients who took Vioxx for a short period may have been at risk for heart trouble.

Researchers at Oxford University in the United Kingdom conducted the Victor study and while scientists there gave the company preliminary data, they haven’t yet provided the full results. “We have asked for it more than once,” said a spokesman for Merck’s attorney. A company spokeswoman added that “Merck believes that Oxford is working diligently to get us the data as it becomes available.”

Oxford said in a statement that the data are being “cleaned” and will be submitted to Merck this Friday, “as previously agreed with Merck.” It says the final results likely won’t be published until 2008.

A Merck spokeswoman cautioned that “one cannot draw scientifically meaningful conclusions based on small amounts of data from a prematurely terminated study.”

Merck ended the Victor study last September—and voluntarily took Vioxx off the market—after preliminary results of another study, called Approve, showed a heightened risk of heart attack and stroke in Vioxx users after 18 months, though the numbers were small. The difference didn’t become statistically significant until after 30 months, a point that Merck is now emphasizing, particularly in the case under way, in Texas state court.

That Vioxx may have posed an increased risk even earlier could have major implications for the legal cases being filed against Merck. Out of 20 million Americans estimated to have taken Vioxx, only a small percentage of them are likely to be able to claim that they took the painkiller every day for more than a year and a half. The Victor results could provide ammunition for those litigants who took Vioxx for shorter periods of time.

Merck’s liability has been estimated at between $4 billion and more than $20 billion.

Merck points out that the Victor results are still tentative, and that preliminary results for another clinical trial it halted last year, called Vip, didn’t show an increased risk for Vioxx. In fact, 15 patients on placebo had adverse cardiovascular events, compared with 14 who actually took the drug.

According to the newly released document, a Merck researcher last February created a graph that showed the results of the Victor trial based on the information that the company had at the time. Though the numbers were small, the graph showed an almost immediate and wide difference in “thrombotic cardiovascular events,” such as heart attacks, between Vioxx and placebo users. After six months, the Vioxx users had experienced eight “thrombotic” events, compared with three on placebo. After a year, 10 Vioxx users had thrombotic events, versus three in the placebo group.

By the time the trial was halted, after 24 months, there were 12 events reported among Vioxx users compared with four events in the placebo group. The Victor trial enrolled more than 2,300 patients—a similar number to those enrolled in the Approve study, which led to the drug’s withdrawal. “We’re still double-checking the programs,” said the Merck researcher in an email about the Victor data, “but I don’t expect the overall picture to change.”

A spokesman for Merck’s lead outside attorney said that the number of thrombotic events on the graph are accurate, but emphasized that not all the data have been received. Based on the information available to Merck, he said, the difference at six months wasn’t statistically significant and thus could have been due to chance, while the difference at one year was “almost” statistically significant. The company said that interpretation of the magnitude and importance of the results will be made more difficult by the early halt of the study.

Ted Mayer, Merck’s lead outside attorney, in a statement acknowledged that in the Victor study, the rate of events on Vioxx was higher than placebo, but he noted that in the Vip trial, the rates were lower, though not by much. In addition, he said the Victor trial results have to be weighed against four other studies: Approve, Vip and two studies of Alzheimer’s patients that did not show an increased risk of heart attacks or strokes.

The fact that there was an almost immediate difference in heart attacks and strokes in the Victor clinical trial poses a challenge in New Jersey state court, where Merck faces its second lawsuit in September. In that case, Mike Humeston, an avid hiker, was 56 when he took Vioxx for knee pain in 2001. Two months later, he suffered a heart attack, according to his lawyer Christopher Seeger, of Seeger Weiss in New York. Mr. Humeston survived, but his heart is permanently damaged and he can no longer do the rugged physical activities he used to enjoy, Mr. Seeger said.

Mr. Seeger says his client was very healthy before taking Vioxx, having low cholesterol and low blood pressure and no history of heart disease. Mr. Seeger says that the fact that only one of Mr. Humeston’s heart vessels appeared to be damaged after his heart attack is a sign that he didn’t have longstanding heart disease. Mr. Humeston declined to comment. In New Jersey, Mr. Seeger only has to prove that Vioxx contributed to his client’s heart attack to win.

The Victor trial “is absolutely going to play a role” in the Humeston trial, said Mr. Seeger. “The most important part of Victor is the lines beginning to separate almost immediately.”

In a statement, Mr. Mayer said, “We do not believe Vioxx could or did cause his heart attack.”

Meanwhile, in the Texas case yesterday, plaintiff attorney Mark Lanier surprised Merck by announcing that he was planning to put the coroner on the stand, even though Merck attorneys have never deposed her. The coroner wrote on the death certificate that 59-year-old triathlete Robert Ernst died of an arrhythmia, an irregular heart beat. Since Merck has said there is no scientific evidence to link Vioxx with arrhythmias, Mr. Lanier has been trying to show that Mr. Ernst had a heart attack first, which caused an arrhythmia that led to his death. Mr. Lanier said that the coroner’s testimony will help his case substantially. “We are not worried about the testimony,” a Merck attorney said in a statement.

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